Aclitol Cozycap DPI (Dry-Powder Inhaler) is used for: Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD) 1 inhalation PO BID Not to exceed 1 inhalation BID

Severe hypersensitivity to milk proteins Hypersensitivity to aclidinium bromide, formoterol fumarate, or any product component Not indicated for asthma; use of long-acting beta2-adrenergic agonists (LABAs), including formoterol fumarate, without an inhaled corticosteroid is contraindicated in patients with asthma

Side effects of Aclidinium Bromide+ Formoterol Fumarate inhaler : 1-10% Upper respiratory tract infection (8.9%) Headache (6.3%) Back pain (3.8%) Cough (1-3%) Sinusitis (1-3%) Influenza (1-3%) Tooth abscess (1-3%) Insomnia (1-3%) Dizziness (1-3%) Dry mouth (1-3%) Oropharyngeal pain (1-3%) Muscle spasms (1-3%) Musculoskeletal pain (1-3%) Arthralgia (1-3%) Pain in extremity (1-3%) Urinary tract infection (1-3%) Blood creatine phosphokinase increased (1-3%)

Pregnancy There are no adequate and well-controlled studies of aclidinium/formoterol or its individual components in pregnant women to assess drug-associated risks Animal studies No adverse developmental effects were seen with inhalation administration of aclidinium bromide to pregnant rats and rabbits during organogenesis at 15 or 20 times, respectively, the maximum recommended human daily inhaled dose (MRHDID) Formoterol fumarate alone, administered by the oral route, was teratogenic in rats and rabbits at 1,200 and 49,000 times the MRHDID, respectively Formoterol fumarate was also embryocidal, increased pup loss at birth and during lactation, and decreased pup weight in rats at 85 times the MRHDID Labor or delivery No well-controlled human studies Because of the potential for beta-agonist interference with uterine contractility, use of during labor should be restricted to those patients in whom the benefits clearly outweigh the risk Lactation There are no available data on the breastfed child or on milk production or presence in human milk Both aclidinium bromide and formoterol fumarate are present in rat milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk Animal studies Aclidinium bromide reduced pup weights when pregnant rats continued inhalation administration through lactation at 5 times the MRHDID Formoterol fumarate increased pup loss at birth and during lactation, and decreased pup weight in rats at 85 times the MRHDID

Aclidinium: Long-acting muscarinic antagonist (LAMA), often referred to as an anticholinergic, has specificity for muscarinic receptors with affinity for the M3 (subscript) receptor in the airways; produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle Formoterol: Long-acting selective beta-2 agonist (LABA); elicits bronchial smooth muscle relaxation by stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP); increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibit release of mediators of immediate hypersensitivity from cells, especially from mast cells